The FDA is conducting a national listening tour, engaging directly with pharmaceutical and biotech CEOs to address concerns about the U.S. lagging behind China in drug development1.
China's National Medical Products Administration (NMPA) is proposing to halve clinical trial review times for novel medicines, which could set the review period to 30 days and further accelerate already rapid drug development compared to the U.S.4.
A significant shift has occurred in licensing:
by 2024, about one-third of new drug compounds licensed by U.S. pharmaceutical companies originated from Chinese biotechnology firms, up from none five years prior34.
The U.S. is seen as hampered by increasing regulatory burdens and higher costs for early-stage drug development, especially Phase I clinical trials, whereas China offers lower costs and faster timelines35.
Industry leaders and former FDA officials stress the need for regulatory reform in the U.S. to avoid further loss of drug discovery and development leadership to China35.
Economists note that while the U.S. leads in basic science and biotech innovation, it is hindered by declining R&D efficiency, with drug development costs rising and returns shrinking over the past decade5.
Sources:
1. https://www.fda.gov/industry/ceo-forums-fda-listening-tour-engage-pharma-ceos
3. https://www.statnews.com/2025/05/06/how-to-stop-the-shift-of-drug-discovery-from-the-u-s-to-china/
4. https://www.fiercebiotech.com/biotech/accelerate-drug-development-china-proposes-shorten-clinical-trial-review-time
5. https://www.statnews.com/2025/06/03/us-vs-china-biotech-regulation-erooms-law-high-speed-review-trials/